Responsibilities :

1. To appoint Principal Analytical Investigator during the preparation of study protocol or method validation protocol.

2. To identify the Principal Analytical Investigator for method development, method validation projects.

3. To identify the Principal Analytical Investigator for BA/BE and PK endpoint projects for analysis of biological samples.

4. To ensure training to all personnel in Bioanalytical operations as per their Job descriptions. To ensure training of the contractual staff in the respective area.

5. To ensure GCP/GLP training to all personnel in Bioanalytical operations.

6. To ensure functioning of the department in accordance with the applicable GLP principles and current regulatory requirements.

7. To ensure that the SOPs are available for every function of bioanalytical.

8. To review SOPs to meet regulatory requirements.

9. To ensure that all activities are conducted in adherence to SOPs and current regulatory guidelines.

10. To co-ordinate with other departments and external customers for business activities.

11. To ensure safety in the department.

12. To ensure closure of change controls.

13. To review deviations and ensure closure of CAPA.

14. To ensure proper planning of all project activities to meet business needs.

15. To ensure periodic maintenance, calibration and qualification of instruments.

16. To involve in procurement of instruments/equipment for bioanalytical department and ensure the installation, operational and performance qualification of instruments.

17. To ensure validation of critical software used in the bioanalytical department.

18. To give technical guidance on development of bioanalytical methods.

19. To ensure effective management of biological samples.

20. To take corrective and preventive action on any unforeseen even that may affect the quality and integrity of study.

21. To ensure compliance to QA observations.

22. To ensure timely response to regulatory queries and deficiency letters.

23. To attend regulatory audits.

24. To prepare bio-analytical budget.

25. To involve in recruitment of bioanalytical staff.

26. To ensure archival of study data.

27. To identify the potential employees for enhancing/enlarging job responsibilities.

28. To assist and support unit head in new business initiatives